StressNCT03662867
Applying Mindfulness for Economically Disadvantaged Families
A study testing Family-based mindfulness intervention and Wait-list in people with Stress, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The purpose of this study is to assess the effectiveness of a family-based mindfulness intervention (FBMI) in reducing parental stress and promoting child adjustment. Intervention effectiveness will be tested by conducting a randomized controlled trial comparing a group receiving FBMI to a wait-list control group. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Family-based mindfulness intervention and Wait-list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Jan 2016to 13 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Monthly household income below one half of the median of those in Hong Kong
- Children aged between 5 to 7
- Both children and at least one of their parents agreed to participate in the program
Who cannot join
- Children or parents with physical disability or mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Mindfulness Training in a Family-based Intervention for Improving Early Child Development and Stress Management in Economically Disadvantaged Families
The purpose of this study is to assess the effectiveness of a family-based mindfulness intervention (FBMI) in reducing parental stress and promoting child adjustment. Intervention effectiveness will be tested by conducting a randomized controlled trial comparing a group receiving FBMI to a wait-list control group. Children aged five and their parents will be recruited to participate in the study. Eligible families will be recruited, stratified by level of economically disadvantage, behaviour problem scores, and parental stress, and then randomly assigned to the two groups. Intervention groups will be conducted by instructors with professional training. Children in the intervention group are expected to show improvements in cognitive and language development, behaviour problems, attention and emotional/behavior regulation, and physiological stress (reduced cortisol and heart rate variability), compared with the waitlist control group. Parents are expected to show improvements in physiological and psychological stress, and mindfulness, compared with the waitlist control group.
Read the detailed description
Economic disadvantage has been found to be associated with delayed cognitive and language development, and mental health symptoms such as aggression, anxiety of children. Chronic cumulative stressors of poverty disrupt their attention, emotional and behavioural regulation, that would further lead to negative impact in early development. As their parents are also affected by stress, they often become unresponsive, harsh and inconsistent in child discipline, resulting in a chronic stress to their children. Mindfulness is defined as paying attention purposefully and non-judgmentally to the present moment. It has been shown to improve attention, promote exposure to unpleasant experiences, facilitate cognitive change, and enhance the ability to cope with life stress. Mindfulness training has been established as an evidence-based intervention for people suffering from various chronic conditions. Its application in a family context, including parents and children, is just beginning. The purpose of this study is to assess the effectiveness of a family-based mindfulness intervention (FBMI) in reducing parental stress and promoting child adjustment. Intervention effectiveness will be tested by conducting a randomized controlled trial comparing a group receiving FBMI to a wait-list control group. Children aged five and their parents will be recruited to participate in the study. Eligible families will be recruited, stratified by level of economically disadvantage, behaviour problem scores, and parental stress, and then randomly assigned to the two groups. Intervention groups will be conducted by instructors with professional training. Children in the intervention group are expected to show improvements in cognitive and language development, behaviour problems, attention and emotional/behavior regulation, and physiological stress (reduced cortisol and heart rate variability), compared with the waitlist control group. Parents are expected to show improvements in physiological and psychological stress, and mindfulness, compared with the waitlist control group. The proposed project will be the first of its kind to use mindfulness training in a family context in Hong Kong. It is also unique as it examines the effectiveness of a mindfulness-based intervention with multiple outcome measures related to stress, combining self-reported measures with biomarkers, and psychological tests. For model building and theory development, this study may shed light on assessing the change mechanisms for promoting child learning, emotional and behavioural regulation, particularly in relation to studies of stress physiology and economically disadvantaged families. The results may not only benefit in Hong Kong but also those in other Chinese societies and countries.
- Conditions
- Stress
- Being tested
- Family-based mindfulness intervention, Wait-list
- Keywords
- mindfulness training, economically disadvantaged families, family-based interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based mindfulness interventionBehavioural
For the parent program of family-based mindfulness intervention, the content includes: guide body scan practice; guide stretching exercise and mindful breathing; guide practice of mindfulness to breath and body; teach three-minute breathing exercise; guide joint session and let parents practice mindfulness with children; guide mindfulness practice of exploring difficulties; and teach loving-kindness practice.
For the child program, the content includes: guide mindful breathing exercise; guide mindful movement exercises; use stories of animal characters to guide body scan exercise; guide mindful eating and mindful walking exercise; tell stories about different emotions and guide discussion; guide the imagination exercise about different emotions; and guide loving-kindness practice.
Wait-listOther
No intervention is given between T1 and T2. Family-based mindfulness intervention would be received after posttest of intervention groups.
| Study group | Role | What they receive |
|---|---|---|
| Family-based mindfulness intervention | Experimental | Family-based mindfulness intervention is a parallel-group intervention containing one parent program and one child program. The parent mindfulness program lasts for 6 weeks, one session per week, and each session lasts for 1.5 hours. The child mindfulness program lasts for 8 weeks, one session per week, and each session lasts for 1 hour. In the fourth and sixth sessions of the parent program, 30-minute joint practice of parents and children is incorporated. All sessions are implemented by qualified instructors. Receives: Behavioral: Family-based mindfulness intervention |
| Wait-list control | Other | Intervention group participants were assessed at baseline (T1) and after the intervention (T2). Control group participants were assessed at the same time with the intervention group, and would receive the same program after posttest of intervention groups. Receives: Other: Wait-list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Child Cognitive Development and Behaviour Regulation at 8 weeks
Assessed by counting test and head-shoulder-knee-toe test
Measured: (1) Pretest baseline, and (2) through intervention completion, 8 weeks
Secondary outcomes (8)
Change from Baseline Parental Stress at 8 weeks and at 3 months
Assessed by parent-reported scale, named Parenting Stress Index-Short Form (PSI-SF), assessing the level of parenting stress from different sources of difficulties.
Total Stress (TS) score and three sub-scores, including Parental Distress (PD), Parental-Child Dysfunctional Interaction (PCDI) and Difficult Child (DC), are reported.
For the range of TS, the minimum score is 36 and the maximum score is 180. Higher values represent a higher level of total parenting stress.
For the range of PD, PCDI and DC, the minimum scores are 12 and the maximum scores are 60. Higher values represent a higher level of parenting stress respectively from the source of parental distress, parental-child dysfunctional interaction, and difficult child.
Three sub-scores are summed to compute a total score.
Measured: (1) Pretest baseline, and (2) 3-month follow up after intervention completion
Change from Baseline Parent Depression at 8 weeks and at 3 months
Assessed by parent-reported scale, named Patient Health Questionnaire-9 (PHQ-9), assessing the construct of parent's depression symptoms, directly based on the nine diagnostic criteria for major depressive disorder in the DSM-IV (Diagnostic and Statistical Manual Fourth Edition).
One total score is reported. For the range of the total score, the minimum score is 0 and the maximum score is 27. Higher values represent parents' more severe level of depression symptoms.
Measured: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
Change from Baseline Mindfulness in Parenting at 8 weeks and at 3 months
Assessed by parent-reported scale, named Interpersonal Mindfulness in Parenting (IM-P) scale, assessing the construct of parent's quality of mindfulness specific to his or her family context.
The total score and four subscale scores, including Compassion for Child (CC), Emotional Awareness in Parenting (EAP), Nonjudgmental Acceptance in Parenting (NAP) and Listening with Full Awareness (LFA), are reported.
The range of the total score is 23 to 115. Higher values represent parents' better quality of mindfulness in parenting.
The range of CC is 7 to 35. Higher values represent parents' better quality of compassion for child.
The range of EAP and NAP is 6 to 30. Higher values respectively represent parents' better quality of emotional awareness in parenting and nonjudgmental acceptance in parenting.
The range of LFA is 4 to 20. Higher values represent parents' better quality of listening with full awareness.
Four subscale scores are summed to compute a total score.
Measured: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
Change from Baseline Physiological Stress indicated by salivary cortisol at 8 weeks
Assessed by enzyme-linked immunoassay kit
Measured: (1) Pretest baseline, (2) through intervention completion, 8 weeks
Change from Baseline Physiological Stress indicated by heart rate variability at 8 weeks and at 3 months
Assessed by electrocardiogram (ECG)
Measured: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
Change from Baseline Family Functioning at 8 weeks and at 3 months
Assessed by parent-reported scale, named Family APGAR scale, assessing parent's satisfaction of family functions.
One total score is reported. For the range of the total score, the minimum score is 0 and the maximum score is 10.
Higher values represent parent's better satisfaction of family functions.
Measured: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
Change from Baseline Child Behavior Problem at 8 weeks and at 3 months
Assessed by parent-reported scale, named Child Behavior Checklist (CBCL), assessing parents' ratings of their children's behavior problems.
The Total Problem, and seven subscale scores, including Internalizing Problems, Externalizing Problems, Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Attention Problems, and Aggressive Behavior, are reported.
For the range of Total Problem and all subscale scores, including Internalizing Problems, Externalizing Problems, Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Attention Problems, and Aggressive Behavior, the minimum scores are 0 and the maximum scores are 1. Higher values respectively represent children's more severe level of overall behavioral problems, Internalizing Problems, Externalizing Problems, Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Attention Problems, and Aggressive Behavior.
All of them are calculated as the sum of corresponding scale items, and standardized.
Measured: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
Change from Baseline Child Attention at 8 weeks and at 3 months
Assessed by computer-aided Attention Network Test (ANT), assessing children's efficiency of attention networks according to their response time to stimuli.
Measured: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start22 Jan 2016
- Primary completion13 Jul 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- University Grants Committee, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Hay-ming Herman Lo, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662867
- Sponsor's protocol ID
- 21611415
- Status last verified
- Sep 2017
- First submitted
- 20 Sep 2017
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Mindfulness Training in a Family-based Intervention for Improving Early Child Development and Stress Management in Economically Disadvantaged Families
- ClinicalTrials.gov ID
- NCT03662867
- Acronym / sponsor ID
- 21611415
- Conditions
- Stress
- Keywords
- mindfulness training, economically disadvantaged families, family-based interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- University Grants Committee, Hong Kong
- Study start
- 22 Jan 2016 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effectiveness of a family-based mindfulness intervention (FBMI) in reducing parental stress and promoting child adjustment. Intervention effectiveness will be tested by conducting a randomized controlled trial comparing a group receiving FBMI to a wait-list control group. Children aged five and their parents will be recruited to participate in the study. Eligible families will be recruited, stratified by level of economically disadvantage, behaviour problem scores, and parental stress, and then randomly assigned to the two groups. Intervention groups will be conducted by instructors with professional training. Children in the intervention group are expected to show improvements in cognitive and language development, behaviour problems, attention and emotional/behavior regulation, and physiological stress (reduced cortisol and heart rate variability), compared with the waitlist control group. Parents are expected to show improvements in physiological and psychological stress, and mindfulness, compared with the waitlist control group.
Detailed description
Economic disadvantage has been found to be associated with delayed cognitive and language development, and mental health symptoms such as aggression, anxiety of children. Chronic cumulative stressors of poverty disrupt their attention, emotional and behavioural regulation, that would further lead to negative impact in early development. As their parents are also affected by stress, they often become unresponsive, harsh and inconsistent in child discipline, resulting in a chronic stress to their children. Mindfulness is defined as paying attention purposefully and non-judgmentally to the present moment. It has been shown to improve attention, promote exposure to unpleasant experiences, facilitate cognitive change, and enhance the ability to cope with life stress. Mindfulness training has been established as an evidence-based intervention for people suffering from various chronic conditions. Its application in a family context, including parents and children, is just beginning. The purpose of this study is to assess the effectiveness of a family-based mindfulness intervention (FBMI) in reducing parental stress and promoting child adjustment. Intervention effectiveness will be tested by conducting a randomized controlled trial comparing a group receiving FBMI to a wait-list control group. Children aged five and their parents will be recruited to participate in the study. Eligible families will be recruited, stratified by level of economically disadvantage, behaviour problem scores, and parental stress, and then randomly assigned to the two groups. Intervention groups will be conducted by instructors with professional training. Children in the intervention group are expected to show improvements in cognitive and language development, behaviour problems, attention and emotional/behavior regulation, and physiological stress (reduced cortisol and heart rate variability), compared with the waitlist control group. Parents are expected to show improvements in physiological and psychological stress, and mindfulness, compared with the waitlist control group. The proposed project will be the first of its kind to use mindfulness training in a family context in Hong Kong. It is also unique as it examines the effectiveness of a mindfulness-based intervention with multiple outcome measures related to stress, combining self-reported measures with biomarkers, and psychological tests. For model building and theory development, this study may shed light on assessing the change mechanisms for promoting child learning, emotional and behavioural regulation, particularly in relation to studies of stress physiology and economically disadvantaged families. The results may not only benefit in Hong Kong but also those in other Chinese societies and countries.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-based mindfulness intervention | Experimental | Behavioral: Family-based mindfulness interventionFamily-based mindfulness intervention is a parallel-group intervention containing one parent program and one child program. The parent mindfulness program lasts for 6 weeks, one session per week, and each session lasts for 1.5 hours. The child mindfulness program lasts for 8 weeks, one session per week, and each session lasts for 1 hour. In the fourth and sixth sessions of the parent program, 30-minute joint practice of parents and children is incorporated. All sessions are implemented by qualified instructors. |
| Wait-list control | Other | Other: Wait-listIntervention group participants were assessed at baseline (T1) and after the intervention (T2). Control group participants were assessed at the same time with the intervention group, and would receive the same program after posttest of intervention groups. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Monthly household income below one half of the median of those in Hong Kong
- Children aged between 5 to 7
- Both children and at least one of their parents agreed to participate in the program
Key exclusion criteria (1 listed)
- Children or parents with physical disability or mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-based mindfulness interventionFor the parent program of family-based mindfulness intervention, the content includes: guide body scan practice; guide stretching exercise and mindful breathing; guide practice of mindfulness to breath and body; teach three-minute breathing exercise; guide joint session and let parents practice mindfulness with children; guide mindfulness practice of exploring difficulties; and teach loving-kindness practice. For the child program, the content includes: guide mindful breathing exercise; guide mindful movement exercises; use stories of animal characters to guide body scan exercise; guide mindful eating and mindful walking exercise; tell stories about different emotions and guide discussion; guide the imagination exercise about different emotions; and guide loving-kindness practice. | Behavioural | Family-based mindfulness intervention |
| Wait-listNo intervention is given between T1 and T2. Family-based mindfulness intervention would be received after posttest of intervention groups. | Other | Wait-list control |
Primary outcome
Change from Baseline Child Cognitive Development and Behaviour Regulation at 8 weeks
Time frame: (1) Pretest baseline, and (2) through intervention completion, 8 weeks
Assessed by counting test and head-shoulder-knee-toe test
8 secondary outcomes
Change from Baseline Parental Stress at 8 weeks and at 3 months
Time frame: (1) Pretest baseline, and (2) 3-month follow up after intervention completion
Change from Baseline Parent Depression at 8 weeks and at 3 months
Time frame: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
Change from Baseline Mindfulness in Parenting at 8 weeks and at 3 months
Time frame: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
Change from Baseline Physiological Stress indicated by salivary cortisol at 8 weeks
Time frame: (1) Pretest baseline, (2) through intervention completion, 8 weeks
Change from Baseline Physiological Stress indicated by heart rate variability at 8 weeks and at 3 months
Time frame: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
Change from Baseline Family Functioning at 8 weeks and at 3 months
Time frame: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
Change from Baseline Child Behavior Problem at 8 weeks and at 3 months
Time frame: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
Change from Baseline Child Attention at 8 weeks and at 3 months
Time frame: (1) Pretest baseline, (2) through intervention completion, 8 weeks, and (3) 3-month follow up after intervention completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hay-ming Herman Lo, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based mindfulness intervention and Wait-list in people with Stress, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Child Cognitive Development and Behaviour Regulation at 8 weeks (time frame: (1) Pretest baseline, and (2) through intervention completion, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.